Reviewed by Stephen M Perle, College of
Chiropractic, University of Bridgeport, Bridgeport, CT O6601, USA

Using a
generic consent form is desirable in the informed-consent process, but such
forms may not give potential subjects an adequate understanding of a
project.Attention to several aspects
of design and content of the form will assist comprehension.A form matched to the knowledge and reading
ability of the typical subject should be supplemented with verbal information
for those who do not or cannot read the form properly. Reprint pdf · Reprint doc

Informed consent is an important part of a research project involving
human subjects. The consent process is based on two fundamental ethical
principles: protecting subjects (non-maleficence) and allowing potential
subjects freedom of choice (autonomy). In a previous article at this site, we
presented elements of an informed-consent document that help achieve these
aims. Here we make suggestions aimed at improving a potential subject's
understanding of the information and consent form, and we provide a generic
(standardized) form.

Recent
research has shown that a substantial proportion of consent documents do not
cater adequately for subjects who have low reading levels. In a study
examining information leaflets given to palliative care patients in Britain,
only 40% of the population would have had enough understanding to give
informed consent.Many of these
documents did not meet basic guidelines on legibility and readability (Payne
et al., 2000).In sport psychology,
Cardinal et al. (1996) found that more than 85% of consent forms were at a
reading level termed “difficult” or “very difficult”. Here are some
suggestions to improve readability of the informed-consent document…

4.Ethical principles, such as such
as the right to withdraw, opportunity to ask questions, and statement of
risks, are more likely to be dealt with, and therefore…

5.Researchers and the institution
may have more protection from litigation.

A generic
form should be more comprehensible than one written entirely by researchers,
but the researcher still needs to insert information on aims, procedures,
risks, benefits, and safety unique to each project. This information might be
hard for a subject to understand, so we still advise researchers to obtain
readability statistics on the completed document and then to pilot test it.

When we
added specific information to our generic
form, we obtained a Flesch Reading Ease score of 68.5.The higher the Reading Ease score, the
easier it is to understand the document.For most standard documents, you should aim for a score of 60-70
(Flesch, 1948). Even so, reducing the reading level of an informed consent
form may have little effect on a subject's ability to understand the document
(Cardinal, 2000).Ideally you should
pilot test the understanding on a sample of subjects representative of the
intended study population.Input from
a colleague in your department or in another discipline might also be
helpful.

You
should always give a verbal explanation about the project, for the benefit of
those subjects with poor reading skills or a careless attitude to fine print.
Providing the opportunity for subjects to ask questions and have them
answered is also an obligatory part of the consent process

Remember
that a comprehensible consent form alone does not protect a subject, other
than by providing information on which to make a choice.The nature of the project–the research
design, the procedures, and the ethical review process itself–must all be
ethically acceptable.